BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 18436519 · Received January 3, 2024

    Report

    Report Number
    1119779-2024-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    November 24, 2023
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #:(B)(6). BD PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. PMA / 510(K)#: K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K163637, K173252, K173523, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K190905. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 09-JAN-2024. INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR HIGH MIC CEFEPIME (FEP) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 3269849. THE CUSTOMER PROVIDED PANEL RETURNS, ISOLATE RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB RESULTS SHOW HIGH MIC RESULTS WITH P. AERUGINOSA WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, TWO RETENTION PANELS EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA T181264 AND P. AERUGINOSA F900603 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. ALSO, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA T181264 AND P. AERUGINOSA F900603 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. LAST, ONE CUSTOMER RETURNED PANEL WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE P. AERUGINOSA T181264 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. DISC DIFFUSION WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATES TO VERIFY FEP SUSCEPTIBILITY. RESULTS OF THE INVESTIGATION RETURNED THE EXPECTED RESULTS FOR FEP. THIS COMPLAINT IS NOT CONFIRMED. THE BREAKPOINTS PUBLISHED IN CLSI M100, 33RD ED /M45-A3 REMAIN UNCHANGED IN THE BD PHOENIX¿, BD EPICENTER¿, AND BD SYNAPSYS¿ SYSTEMS. THE PUD BREAKPOINTS LISTED IN THIS TABLE ARE NOT ALIGNED WITH THE CURRENT CLSI M100 BREAKPOINTS EITHER DUE TO THESE BREAKPOINTS NOT BEING RECOGNIZED BY THE FDA SUSCEPTIBILITY TESTING INTERPRETIVE CRITERIA (STIC) WEBSITE OR PERFORMANCE WITH THE UPDATED BREAKPOINTS HAS NOT YET BEEN EVALUATED INTERNALLY BY BD FOR THE BD PHOENIX ¿ SYSTEM. AS BD PHOENIX¿ CURRENTLY HAS ONLY ONE CLSI INTERPRETATIONAL RULE SET, THIS BREAKPOINT SET IS INFLUENCED BY THE FDA FOR US CUSTOMERS. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG CEFEPIME WHEN COMPARED TO THE KIRBY BAUER (KB) DISK RESULT. THE PANEL RESULT WAS RESISTANT WHILE THE KB WAS INTERMEDIATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG CEFEPIME WHEN COMPARED TO THE KIRBY BAUER (KB) DISK RESULT. THE PANEL RESULT WAS RESISTANT WHILE THE KB WAS INTERMEDIATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762778 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3269849 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown